{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "26305", "product_res_number": "Z-0662-03", "event_date_initiated": "2002-01-25", "event_date_posted": "2003-03-20", "recall_status": "Terminated", "event_date_terminated": "2012-07-13", "res_event_number": "25706", "product_code": "EQJ", "product_description": "Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows:\nPart Number 31-55631 Oto-Flex carbide 1.0mm Bur;\nPart Number 31-55632 Oto-Flex carbide 2.3mm Bur;\nPart Number 31-55642 Oto-Flex diamond 2.3mm Bur;\nPart Number 31-55647 Oto-Flex diamone 0.7 mm Bur\nPART NUMBER AND LOT NUMBER IS LISTED ON POUCH AND BOX LABEL.", "code_info": "Part No. 31-55631, lot number 27066500 Part No. 31-55632, lot number 27111700 Part No. 31-55642, lot number 27135800 Part No. 31-55647, lot number 27123300", "firm_fei_number": "1045254", "recalling_firm": "Medtronic Xomed, Inc.", "address_1": "6743 Southpoint Dr, N. 6743 Southpoint Dr N.", "city": "Jacksonville", "state": "FL", "postal_code": "32216", "additional_info_contact": "B.L. McDermott, RAC\n800-874-5797", "reason_for_recall": "Product packaging pouches may be open thereby compomising the sterile barrier.", "root_cause_description": "Other", "action": "A recall notification letter and Effectiveness Response Form were Federal Expressed Overnight Delivery to the attention of the Risk Manager at each consignee on 1/25/2003. Consignees were requested to respond and return recalled product to Medtronic Xomed in Jacksonville, FL. or they can destroy them and request credit.", "product_quantity": "120", "distribution_pattern": "Product was distributed to hospitals in the follwoing US states: CO, VA, MA, CA, HI, ID, VT, NY, NC, OK, MO, TX, GA, AND AL. there were no military or government accounts. There were nine international accounts as follows (all distributors):\n1- Kir-Op AS, Biskop Jens Nilssonsgt 5A, Postal Box 6631 Etterstad 0607 Oslo, Norway.\n2- Kebo Care Dema, Jerholmen 41, DK 2650 Hvidovre Denmark\n3- Biomedical Technology, Via Tolstoi 7, 20090 Trezzano Sul, Nabiglio, Milan Italy.\n4-Apex Medical Est. Jawad Sikkarieh Bldg., Sweifeh Amman 111121, PO Box 213131 Jordan\n5- Diseven, Carrera 12 No 102-07 Santafe de Bogota Colombia;\n6- Wise Horse, 10F-1 No. 11, Minchuan, Taipei, Taiwan\n7- Medtronic Xomed, Unit 2/446 Victoria Road, Gladesville NSW Australia\n8- Medtronic Xomed France, Saint Aubin Le Monial, 03160 Bourbon L''Archambault France\n9- Medtroni BV Earl Bakenstraat 10, 6422 P J Heerlen, PO BNox 25880 6401 Db Heerlen, The Netherlands", "openfda": { "k_number": [ "K953096", "K960853", "K953370", "K955704", "K041985", "K974232", "K946332", "K802503", "K951526", "K955294", "K950337", "K954912", "K952609", "K161514", "K895738", "K935584", "K893499", "K792028" ], "device_name": "Bur, Ear, Nose And Throat", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4140", "device_class": "1", "registration_number": [ "3014334038", "2648623", "1828288", "9613926", "2083124", "3042940336", "1045834", "3006891611", "3013557562", "3023464160", "1048735", "3016678045", "3003435550", "3040335671", "1058322", "3003418325", "1926681", "3010163695", "8040278", "3003790304", "3008887731", "3009460127", "1526711", "1032347", "3017210488", "1928237", "3010202439", "3013784566", "1061124", "3014023545", "1052728", "3015453963", "1313525", "9616696", "3005382983", "1017294", "3015967359", "3013247477", "3012494290", "3009417901", "3011050570", "2648666", "8010516", "3018094310", "9610617", "3013893019", "1526534", "3043148563", "3005575604", "3005820796", "3005440795", "1058084", "3003120897", "1625507", "3005333358", "9610773", "1649518", "1824199", "3004608878", "3002809144", "9680837", "3001644167", "3005809810", "1526611", "9612501", "1045254", "1030489", "3010707607", "2649614", "3032391", "1932180", "1836161", "2020550", "1646747", "3014342096", "3010155648", "8030607", "1057421", "3010726901", "1058584", "3003800209", "3010173425", "9611253", "1037007", "3014479313", "3021632375", "3043648115", "3003687489" ], "fei_number": [ "3014334038", "2648623", "1828288", "1000221981", "3002808268", "2083124", "3042940336", "1045834", "3006891611", "3013557562", "1000477302", "3023464160", "1048735", "3016678045", "3003435550", "3040335671", "3003418325", "1926681", "1000119305", "3002750084", "3010163695", "3007475226", "1000022662", "3003790304", "3008887731", "3009460127", "3003249645", "1526711", "3003164255", "3002299608", "1032347", "3017210488", "1928237", "3013784566", "3014023545", "3015453963", "3002807798", "3005382983", "1017294", "3015967359", "3013247477", "1000113735", "1000219637", "3012494290", "3009417901", "3011050570", "2648666", "3018094310", "3013893019", "1526534", "3043148563", "3005575604", "3005820796", "3005440795", "3003120897", "1625507", "3005333358", "1000160162", "1824199", "1000402972", "3004608878", "3002809144", "3002807036", "3001644167", "3005809810", "1526611", "3001236277", "1000512168", "1045254", "3002807687", "1000307631", "3010707607", "2649614", "3006509795", "2020550", "3014342096", "3010155648", "3010726901", "3003800209", "1037007", "3014479313", "3003495548", "3021632375", "3004216008", "1317628", "3043648115", "3004169071", "3003687489" ] } } ] }